PRELUDE - Study of factors affecting the lives of people treated by anti-HIV drugs in long term - FRAN09-014 
Head :
Cohen-Codar Isabelle
Last update : 07/01/2020 | Version : 3 | ID : 113
| General | |
| Identification | |
| Detailed name | Study of factors affecting the lives of people treated by anti-HIV drugs in long term - FRAN09-014 |
| Sign or acronym | PRELUDE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | 909498 |
| General Aspects | |
| Medical area |
Infectious diseases Psychology and psychiatry |
| Health determinants |
Addictions Social and psychosocial factors |
| Keywords | anti-retroviral drugs (ARV) in the long term, factors: daily life, professional life, social life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Cohen-Codar |
| Surname | Isabelle |
| Address | 10, rue d’Arcueil – 94258 RUNGIS |
| Isabelle.Cohen-Codar@abbvie.com | |
| Organization | ABBVIE |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | ABBOTT France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | ABBOTT France |
| Organisation status |
Private |
| Sponsor(s) or organisation(s) responsible | Abbott |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | "Random selection of doctors from the database of doctors working on HIV and listed in the file of the French Medical Board.Patients examined in consultation having the selection criteria and accepting to participate in this study. Each doctor could include 15 patients examined in consultation and meeting the selection criteria." |
| Database objective | |
| Main objective |
Describe the factors affecting the life of individuals treated in the long term by anti-HIV drugs.
Describe the factors affecting the life of individuals treated in the long term by anti-HIV drugs according to their age. Evaluate the correlation between the age, duration of seropositivity, the duration under treatment and the disorders reported. Compare the patient's view and that of his doctor concerning the factors described in the main objective. |
| Inclusion criteria |
* HIV-infected patients, treated with antiretroviral agents for at least 5 years and examined in consultation in their normal care center for monitoring their infection
* Obtaining written consent for the collection and use of personal data |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France and Overseas Départements/Territories |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 04/2010 |
| Date of last collection (YYYY or MM/YYYY) | 07/2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1157 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | The data was collected using the doctor's questionnaire and the patient's self-questionnaire. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Analysis of the data of the study in progress. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
